Oscillating positive respiratory pressure device

ABSTRACT

An oscillating positive respiratory pressure apparatus and a method of performing oscillating positive respiratory pressure therapy. The apparatus includes a housing having an interior chamber, a chamber inlet, a chamber outlet, an exhalation flow path defined between the inlet and the outlet, and a restrictor member rotatably mounted within the interior chamber. The restrictor member has an axis of rotation that is substantially perpendicular to the flow path at the inlet, and includes at least one blocking segment. Rotation of the restrictor member moves the at least one blocking segment between an open position and a closed position. Respiratory pressure at the chamber inlet oscillates between a minimum when the at least one blocking segment is in the open position and a maximum when the at least one blocking segment is in the closed position. By exhaling into the apparatus, oscillating positive expiratory pressure therapy is administered.

RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.15/415,524, filed on Jan. 25, 2017, pending, which is a continuation ofU.S. application Ser. No. 13/966,759, filed on Aug. 14, 2013, now U.S.Pat. No. 9,636,473, which is a continuation of U.S. application Ser. No.12/472,215, filed on May 26, 2009, now U.S. Pat. No. 8,539,951, whichclaims the benefit of U.S. Provisional Application No. 61/056,358, filedon May 27, 2008, expired, all of which are incorporated herein byreference.

TECHNICAL FIELD

The present disclosure relates to a respiratory treatment device, and inparticular, to an oscillating positive respiratory pressure device.

BACKGROUND

Each day, humans may produce upwards of 30 milliliters of sputum, whichis a type of bronchial secretion. Normally, an effective cough issufficient to loosen secretions and clear them from the body's airways.However, for individuals suffering from more significant bronchialobstructions, such as collapsed airways, a single cough may beinsufficient to clear the obstructions.

One type of therapy, utilizing oscillating positive expiratory pressure(“OPEP”), is often used to address this issue. OPEP therapy representsan effective bronchial hygiene technique for the removal of bronchialsecretions in the human body and is an important aspect in the treatmentand continuing care of patients with bronchial obstructions, such asthose suffering from chronic obstructive lung disease. It is believedthat OPEP therapy, or the oscillation of exhalation pressure at themouth during exhalation, effectively transmits an oscillating backpressure to the lungs, thereby splitting open obstructed airways andloosening the secretions contributing to bronchial obstructions.

OPEP therapy is an attractive form of treatment because it can be easilytaught to most hospitalized patients, and such patients can assumeresponsibility for the administration of OPEP therapy throughout theirhospitalization and also once they have returned home. To that end, anumber of portable OPEP devices have been developed.

BRIEF SUMMARY

A portable OPEP device and a method of performing OPEP therapy aredescribed herein. The OPEP device is configurable to maintain desiredoperating conditions. A user may adjust the oscillation frequency bysimply replacing a component of the OPEP device, or by changing thespeed at which that component rotates. Furthermore, administration ofOPEP therapy with the device does not rely on the device's physicalorientation or the ability of its user to manipulate the device duringoperation.

In one aspect, the OPEP device comprises a housing having an interiorchamber, a chamber inlet in communication with the chamber, a chamberoutlet in communication with the chamber, an exhalation flow pathdefined between the inlet and the outlet, and a restrictor memberrotatably mounted within the interior chamber. The restrictor member hasan axis of rotation substantially perpendicular to the exhalation flowpath at the inlet, and includes at least one blocking segment. Therestrictor member may be movable with respect to the inlet such thatrotation of the restrictor member moves the at least one blockingsegment between an open position where the flow path at the inlet isunrestricted and a closed position where the flow path at the inlet isrestricted. The respiratory pressure at the chamber inlet oscillatesbetween a minimum when the at least one blocking segment is in the openposition and a maximum when the at least one blocking segment is in theclosed position.

In another aspect, the OPEP device comprises a shaft connecting a sourceof rotational energy to the restrictor member. The source of rotationalenergy may also comprise a motor adapted to rotate the shaft.

In another aspect, the OPEP device includes a second restrictor memberrotatably mounted within the interior chamber and operatively connectedto the shaft, the second restrictor member having a at least oneblocking segment. The shaft is moveable along its axis of rotation toposition the second restrictor member with respect to the inlet suchthat rotation of the shaft moves the at least one blocking segment onthe second restrictor member between the open position and the closedposition. A number of blocking segments on the restrictor member and anumber of blocking segments on the second restrictor member may bedifferent.

In another aspect, the source of rotational energy comprises a turbineoperatively connected to the restrictor member and adapted to rotate therestrictor member in response to receiving a flow of air. The OPEPdevice may also comprise a turbine housing surrounding the turbine, theturbine housing having a compressed air inlet configured to receivecompressed air from a compressed air source and an exhaust outlet.

In yet another aspect, the OPEP device may be configured tosimultaneously administer both OPEP and aerosol therapies. The OPEPdevice may include a respiratory portal in fluid communication with theinlet, the respiratory portal including a mouthpiece and a nebulizerport. The mouthpiece may be proximate the nebulizer port. An inhalationflow path is defined between the mouthpiece and the nebulizer port,wherein the inhalation flow path does not traverse the exhalation flowpath defined between the inlet and the outlet.

In another aspect, the restrictor member is configured to rotate inresponse to exhaled air traversing the exhalation flow path. The atleast one blocking segment is configured to move between the openposition and the closed position independent of the exhalation pressureat the inlet. The restrictor member may also be removably mounted withinthe interior chamber.

In one embodiment, an OPEP device includes a housing having an interiorchamber, a chamber inlet in communication with the chamber, a chamberoutlet in communication with the chamber, an exhalation flow pathdefined between the inlet and the outlet, and a restrictor memberrotatably mounted within the interior chamber, the restrictor memberhaving at least one blocking segment and a plurality of vanes configuredto rotate the restrictor member in response to exhaled air traversingthe flow path. The restrictor member is positioned with respect to oneof the inlet or the outlet such that rotation of the restrictor membermoves the at least one blocking segment between an open position, wherethe exhalation flow path at the one of the inlet or the outlet isunrestricted, and a closed position, where the flow path at the one ofthe inlet or the outlet is restricted. The exhalation pressure at thechamber inlet oscillates between a minimum when the at least oneblocking segment is in the open position and a maximum when the at leastone blocking segment is in the closed position. The at least oneblocking segment may have a cross-sectional area greater than across-sectional area of the one of the inlet or the outlet. The housingmay include a one-way valve configured to allow air to enter theinterior chamber through a valve opening. A center of gravity of therestrictor member may be radially offset from the axis of rotation ofthe restrictor member. The restrictor member may also be removablymounted within the interior chamber.

According to another aspect, a method of performing oscillating positiverespiratory pressure therapy is provided. The method includes providingan oscillating positive respiratory pressure apparatus, which mayconsist of a housing defining an interior chamber, a chamber inlet incommunication with the chamber, a chamber outlet in communication withthe chamber, an exhalation flow path defined between the inlet and theoutlet, and a restrictor member having at least one blocking segment anda plurality of vanes. The restrictor member is rotatably mounted in theinterior chamber and positioned such that rotation of the restrictormember moves the at least one blocking segment between an open positionwhere the exhalation flow path at one of the inlet or the outlet isunrestricted and a closed position where the exhalation flow path at theone of the inlet or outlet is restricted. The method may includereceiving exhaled air through the inlet, rotating the restrictor memberin response to receipt of the exhaled air at the plurality of vanes, andoscillating an exhalation pressure between a minimum and a maximum atthe inlet during an exhalation period. The minimum may be achieved whenthe restrictor member is in the open position and the maximum may beachieved when the restrictor member is in the closed position. Therestrictor member may be configured to move between the open positionand the closed position independent of the exhalation pressure at thechamber inlet.

In yet another embodiment, a system for providing oscillatingrespiratory pressure therapy in combination with aerosol therapy isprovided. The system may include an oscillating positive respiratorypressure apparatus having a housing defining a chamber, a chamber inletin communication with the chamber, and a chamber outlet in communicationwith the chamber. An exhalation flow path is defined between the chamberinlet and the chamber outlet. A restrictor member having at least oneblocking segment and a plurality of vanes is rotatably mounted in theinterior chamber and positioned such that rotation of the restrictormember moves the at least one blocking segment between an open positionwhere the exhalation flow path at one of the chamber inlet or thechamber outlet is unrestricted and a closed position where theexhalation flow path at the one of the chamber inlet or the chamberoutlet is restricted. Also, a respiratory portal is adapted forreceiving an aerosol medicament. The system may further include anaerosol therapy apparatus removably connected to the respiratory portalof the oscillating positive respiratory pressure apparatus. The aerosoltherapy apparatus may consist of an aerosol housing having an aerosolchamber for holding an aerosol medicament and an aerosol outletcommunicating with the aerosol chamber for permitting the aerosolmedicament to be withdrawn from the aerosol chamber. The system may alsohave an inhalation flow path defined between the aerosol outlet and auser interface, where the inhalation flow path does not traverse theexhalation flow path defined between the chamber inlet and the chamberoutlet. The aerosol medicament traverses the inhalation flow pathwithout contacting the restrictor member.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a first embodiment of an OPEP devicewith a side portion of the device's housing removed;

FIG. 2 is a perspective view of the embodiment of FIG. 1 with a topportion of the device's housing removed, showing a restrictor member inan open position;

FIG. 3 is a perspective view of the embodiment of FIG. 1 with a topportion of the device's housing removed, showing a restrictor member inan intermediate position;

FIG. 4 is a perspective view of the embodiment of FIG. 1 with a topportion of the device's housing removed, showing a restrictor member ina closed position;

FIGS. 5A-E are top views of various restrictor members;

FIG. 6 is a perspective view of a second embodiment of an OPEP devicewith a side portion of the device's housing removed;

FIG. 7 is a perspective view of a third embodiment of an OPEP deviceattached to a nebulizer;

FIG. 8 is a cross-sectional side view of the embodiment of FIG. 7;

FIG. 9 is a perspective view of a fourth embodiment of an OPEP devicewith a top portion of the device's housing removed;

FIG. 10 is a bottom view of the embodiment of FIG. 9 with a bottomportion of the device's housing removed;

FIG. 11 is a cross-sectional perspective view of the embodiment of FIG.9;

FIG. 12 is a cross-sectional perspective view of a fifth embodiment ofan OPEP device;

FIG. 13 is a cross-sectional side view of the embodiment of FIG. 12showing a restrictor member in a closed position;

FIG. 14. is a cross-sectional side view of the embodiment of FIG. 12showing a restrictor member in an open position;

FIG. 15 is a cross-sectional perspective view of the embodiment of FIG.12 having a one way-valve;

FIGS. 16A-C are top views of various restrictor members suitable for usein the embodiment of FIG. 12;

FIG. 17 is a cross-sectional perspective view of a sixth embodiment ofan OPEP device; and,

FIG. 18 is a cross-sectional perspective view of the embodiment of FIG.17 attached to a nebulizer.

DETAILED DESCRIPTION OF THE PRESENTLY PREFERRED EMBODIMENTS

OPEP therapy is very effective within a specific range of operatingconditions. For example, an adult human may have an exhalation flow rateranging from 10 to 60 liters per minute, and may maintain a staticexhalation pressure in the range of 10 to 20 cm H₂O. Within theseparameters, OPEP therapy is believed to be most effective when changesin the exhalation pressure range from 5 to 20 cm H₂O oscillating at afrequency of 10 to 40 Hz. In contrast, an infant may have a much lowerexhalation flow rate, and may maintain a lower static exhalationpressure, thereby altering the operating conditions most effective forOPEP therapy. As described below, the present invention is configurableso that ideal operating conditions may be selected and maintained.

Referring to FIG. 1, a first embodiment of an OPEP device 130 is shownwith a side portion of a housing 132 removed for purposes ofillustration. In general, the OPEP device 130 comprises a housing 132having an interior chamber 134, a chamber inlet 136, and a chamberoutlet 138. An exhalation flow path 140 is defined through chamber inlet136, the interior chamber 134, and the chamber outlet 138. The housing132 may also be associated with a mouthpiece 139 for receiving exhaledair. Although the mouthpiece 139 is shown in FIG. 1. as being fixedlyattached to the housing 132, it is envisioned that the mouthpiece 139may be removable and replaceable with a mouthpiece 139 of a differentshape or size. Alternatively, other user interfaces, such as breathingtubes or gas masks (not shown) may be associated with the housing 132.Preferably, the housing 132 is openable so that the interior chamber 134and the parts contained therein can be periodically accessed, cleaned,and replaced. The housing 132 may be constructed of any durablematerial, such as a plastic or polymer.

In FIG. 1, the housing 132 and the interior chamber 134 are cylindrical.However, a housing of any shape could be used. Furthermore, the chamberinlet 136 is generally shown as being a single, rectangular inlet.However, the chamber inlet 136 could also be any shape or series ofshapes, such as a plurality of circular inlets. More importantly, itshould be appreciated that the cross-sectional area of the chamber inlet136 influences the ideal operating conditions discussed above. Likewise,the chamber outlet 138 is generally shown as a plurality of apertures,however a single aperture or a number of arrangements of apertures mayalso be used. Although these variables are discussed in general withreference to the embodiment of FIG. 1, it should be understood thatevery embodiment described herein may be varied in a similar manner.

A restrictor member 142 is rotatably mounted within the interior chamber134. The restrictor member 142 also may be constructed of any durableplastic or polymer, such as polypropylene. As shown in FIG. 1, therestrictor member 142 comprises a hub portion 144 and at least oneblocking segment 146 extending outward from the hub portion 144. Therestrictor member 142, however, could be any number of shapes, so longas it may be positionable such that at least one blocking segment 146located on the restrictor member 142 is capable of at least partiallyblocking the chamber inlet 136, as described below.

The restrictor member 142 is connected at the hub portion 144 to a shaft148, such that rotation of the shaft 148 causes rotation of therestrictor member 142. The shaft 148 extends through the housing 132 andmay be operatively connected to a motor 150. The motor 150, along withbatteries (not shown) for powering the motor 150, may be housed within amotor housing (not shown) attached to the OPEP device 130. Although itis preferred that the shaft 148 be adapted for connection to a motor150, it is also envisioned that the shaft 148 could extend through thehousing 132 and be adapted for manual rotation by the user of the OPEPdevice 130.

Referring to FIGS. 2-4, the OPEP device 130 is shown with a top portionof the housing 132 removed for purposes of illustration. In FIG. 2, theOPEP device 130 is shown with the restrictor member 142 and the chamberinlet 136 arranged in an open position. The restrictor member 142 ispositioned in an open position when no blocking segment 146 issubstantially blocking the chamber inlet 136 and when the flow path 140through the cross-sectional area of the chamber inlet 136 issubstantially unrestricted by the restrictor member 142. Thus, when therestrictor member 142 is in an open position, a user of the OPEP device130 may freely exhale into the mouthpiece 139 and the exhaled air maytravel along the exhalation flow path 140 through the chamber inlet 136,into the interior chamber 134, and out the chamber outlet 138. In theopen position, the exhalation pressure at the chamber inlet 136 is at aminimum.

Referring to FIG. 3, the restrictor member 142 is shown in anintermediate position. The restrictor member 142 moves to anintermediate position when the restrictor member 142 is rotated to aposition where a blocking segment 146 is at least partially blocking thechamber inlet 136 and the flow path 140 through the cross-sectional areaof the chamber inlet 136 is at least partially restricted by therestrictor member 142. As a user exhales into the mouthpiece when therestrictor member 142 is in an intermediate position, the exhaled airpasses through the unblocked portion of the flow path 140 and exits theinterior chamber 134 through the chamber outlet 138. If the restrictormember 142 is in an intermediate position moving to an open position(FIG. 2), then the exhalation pressure at the chamber inlet 136 isdecreasing. If the restrictor member 142 is moving to a closed position,the exhalation pressure at the chamber inlet 136 is increasing.

Referring to FIG. 4, the restrictor member 142 is shown in a closedposition. The restrictor member 142 moves to a closed position when therestrictor member 142 is rotated to a position where a blocking segment146 substantially blocks the chamber inlet 136 and the flow path 140through the cross-sectional area of the chamber inlet 136 issubstantially restricted by the restrictor member 142. Thus, when therestrictor member 142 is in a closed position, substantially no exhaledair passes through the chamber inlet 136. It should be understood that acomplete seal need not be formed at the chamber inlet 136 between therestrictor member 142 and the housing 132. A small amount of exhaled airmay be permitted to pass through the chamber inlet 136 when therestrictor member is in the closed position. Nevertheless, in the closedposition, exhalation pressure at the chamber inlet 136 is at a maximum.

When the OPEP device 130 is in operation and the shaft 148 iscontinuously rotated, the restrictor member 142 moves between an openposition, multiple intermediate positions, a closed position, multipleintermediate positions, and back to an open position. Likewise, thecross-sectional area of the flow path 140 through the chamber inlet 136transitions from being substantially unrestricted, to substantiallyrestricted, and back to being substantially restricted. As a result,when the user exhales into the mouthpiece 139, the exhalation pressureat the chamber inlet 136 increases to a maximum as the restrictor member142 moves from an open position to a closed position and decreases to aminimum as the restrictor member 142 returns to an open position. As therestrictor member 142 continues to rotate and periodically restrict theflow path 140 through the chamber inlet 136, the exhalation pressure atthe chamber inlet 136 oscillates between a minimum when the restrictormember 142 is in an open position and a maximum when the restrictormember 142 is in a closed position. This oscillating exhalation pressureeffectively transmits an oscillating back pressure to the lungs, therebysplitting open obstructed airways, and loosening the secretionscontributing to bronchial obstructions.

As previously stated, the housing 130 is preferably openable so that therestrictor member 142 may be accessed. The restrictor member 142 isremovably connected to the shaft 148 such that a user can remove therestrictor member 142 for cleaning or replacement with a new ordifferent restrictor member 142. Referring to FIGS. 5A-E, top views ofmultiple restrictor members 142 are shown. The hub portion 144 of eachrestrictor member 142 has a slot 145 keyed to fit on a correspondingkeyed portion (not shown) of the shaft 148. In this regard, a user isable to easily remove an existing restrictor member 142 for cleaning orreplacement with a new restrictor member 142.

Depending on the prescribed treatment, a user may select from a numberof restrictor members 142, each having a different number of blockingsegments 146. FIGS. 5A-E show an eight blocking segment 146 restrictormember 142 and multiple alternative restrictor members 142 a, 142 b, 142c, 142 d, having anywhere from four to seven blocking segments 146. Bychanging the number of blocking segments 146 on the restrictor member142, the user may change the oscillation frequency of the exhalationpressure generated at the chamber inlet 136 for a given rotation speedof the motor 150. Furthermore, the relative size or shape of theblocking segments 146 on a restrictor member 146 may vary, thusproviding for added variation in the oscillation, if desired.

In addition, the motor 150 may be a variable speed motor controllable bythe user. Although the motor may be configured to rotate the restrictormember back and forth in opposite directions, the restrictor member 142is preferably only rotated in a single direction. By adjusting therotational speed of the motor 150, a user may also adjust theoscillation frequency of the exhalation pressure generated at thechamber inlet 136. This combination of different restrictor members 142and the variable speed motor 150 provides for a highly configurable OPEPdevice 130.

Referring to FIG. 6, a second embodiment of an OPEP device 230 is shownwith a side portion of a housing 232 removed for purposes ofillustration. In general, the OPEP device 230 has a larger housing 232for accommodating multiple restrictor members 242. The housing 232 alsohas an interior chamber 234, a chamber inlet 236, and a chamber outlet238. A flow path 240 is defined through the chamber inlet 236, theinterior chamber 234, and exiting the chamber outlet 238.

Within the interior chamber 234, the restrictor members 242 may eitherbe stacked atop one another and operatively connected to a shaft 248,or, in the alternative, each individually connected to the shaft 248.Furthermore, each restrictor member 242 may have a different number ofblocking segments 246. As in the prior embodiment, the housing 232 isopenable so that a user may remove and replace the restrictor member 242positioned adjacent the chamber inlet 236. Thus, the interior chamber232 may conveniently store multiple restrictor members 242 from whichthe user may choose to position on the shaft 248 adjacent the chamberinlet 236.

Alternatively, the shaft 248 may be moveable along its axis of rotationso that a user may position a different restrictor member 242 adjacentthe chamber inlet 236 simply by sliding the shaft further in or out ofthe housing 232. Therefore, a user can adjust the oscillation frequencywithout opening the housing 232 and replacing the restrictor member 242positioned adjacent the chamber inlet 236, and without adjusting therotational velocity of the shaft 248.

Referring to FIGS. 7-8, a third embodiment of an OPEP device 330 isshown. As shown in FIG. 7, the OPEP device 330 is adapted to connect toan output 360 of a nebulizer 352 for the simultaneous administration ofOPEP and aerosol therapies. The OPEP device 330 generally includes arespiratory portal 354 for fluidly interconnecting the nebulizer 352, amouthpiece 339, and the OPEP housing 332. The OPEP device 330 may beconfigured such that it can be used either in combination with thenebulizer 352 or solely for administration of OPEP therapy. FIG. 7 alsoillustrates a motor housing 356 for housing a motor (not shown) andbatteries (not shown) for supplying power to the motor. A shaft 348 isprovided to transfer rotational motion from the motor to the restrictormember 342.

Referring to FIG. 8, a side view of the respiratory portal 354 is shownwithout the nebulizer 352 for delivery of OPEP therapy only. In FIG. 8,the chamber inlet 336 is located above the interior chamber 334 and thechamber outlet 338 is located directly beneath the mouthpiece 339.However, it should be noted that the chamber inlet 336 and the chamberoutlet 338 may be located elsewhere on the housing 332, as discussed inreference to the previous embodiments.

The respiratory portal 354 includes a nebulizer port 356 adapted forreceiving either the nebulizer output 360 or an end cap 358 forregulating the flow of air through the nebulizer port 356. The end cap358 and the nebulizer output 360 may be removably connected to thenebulizer port 356 by any means, including threaded or snap-onconnections. Both the nebulizer output 360 and the end cap 358 mayinclude a one-way valve 359 configured so that air may enter therespiratory portal 354 through the valve opening 361 on inhalation, butblock the flow of air out of the valve opening 361 upon exhalation.Likewise, the chamber inlet 336 may include a one way valve (not shown)configured so that air may enter the interior chamber 334 through thechamber inlet 336 on exhalation, but be prevented from flowing out ofthe interior chamber 334 upon inhalation.

Thus, when a user of the OPEP device 330 exhales into the mouthpiece339, the one way valve in the end cap 358 or nebulizer output 360closes, the one way valve through the chamber inlet 336 opens, andexhaled air is forced into the interior chamber 334 through the chamberinlet 336. In contrast, when a user of the OPEP device 330 inhales airthrough the mouthpiece 339, the one way valve in the end cap 358 ornebulizer output 360 opens, the one-way valve through the chamber inlet336 closes, and air is drawn through the nebulizer port 356 into theuser's mouth. If the nebulizer 352 is attached, a user inhales medicatedair drawn from the nebulizer 352 upon inhalation. Any of a number ofcommercially available nebulizers may be used. One suitable nebulizer isthe AeroEclipse® II breath actuated nebulizer available from TrudellMedical International of London, Canada. Descriptions of suitablenebulizers may be found in U.S. Pat. No. 5,823,179, the entirety ofwhich is hereby incorporated by reference herein.

As in the previously discussed embodiments, the OPEP device 330administers OPEP therapy to the user during an exhalation period. As auser exhales into the mouthpiece 339, exhaled air is forced through thechamber inlet 336 and into the interior chamber 334. During exhalation,as the restrictor member 342 rotates, and as the blocking segments 346pass by the chamber inlet 336, the exhalation pressure at the chamberinlet 336 oscillates between a minimum when the restrictor member 342 isan open position and a maximum when the restrictor member 342 is in aclosed position.

Alternatively, the OPEP device 330 may also be configured to administeroscillating pressure therapy to the user during both inhalation andexhalation. If the end cap 358 is provided without a one-way valve,inhaled air is drawn from the interior chamber 334 through the chamberinlet 336. In such a configuration, as the restrictor member 342rotates, and as the blocking segments 346 pass by the chamber inlet 336,the inhalation pressure at the chamber inlet 336 oscillates between aminimum when the restrictor member 342 is a closed position and amaximum when the restrictor member 342 is in an open position.

Referring to FIG. 9, a fourth embodiment of an OPEP device 430 is shownwith a top portion of a housing 432 removed for purposes ofillustration. The OPEP device 430 is adapted for connection to acompressed air source (not shown), which may be used to rotate arestrictor member 442. Because compressed air sources are commonly foundin hospital settings, the use of compressed air to rotate the restrictormember 442 is convenient. The OPEP device 430 includes a compressed airinlet 462 for connecting to a compressed air hose (not shown) and anexhaust outlet 464 for discharging the compressed air.

Referring to FIG. 10, a bottom view of the OPEP device 430 is shown witha bottom portion of housing 430 removed. A turbine 466 is rotatablymounted within a turbine housing 468 and includes a plurality of vanes467 configured such that compressed air entering the compressed airinlet 462 causes the turbine 466 to rotate. As the turbine 466 rotates,the compressed air is discharged out the exhaust outlet 464.

Referring to FIG. 11, a cross-sectional perspective view of the OPEPdevice 430 is shown with a top portion of the housing 432 removed. Inthis embodiment, a restrictor member 442 and the turbine 466 are joinedtogether along a radial plane by a connecting member 468. Above theconnecting member 468, a housing 432 surrounds the restrictor member 442and defines an interior chamber 434. Below the connecting member 468, aturbine housing 470 surrounds the turbine 466 and includes thecompressed air inlet 466 and the exhaust outlet 464. Although FIG. 11illustrates the restrictor member 442 and the turbine 466 as beingjoined by the connecting member 468, it should be appreciated that therestrictor member 442 and the turbine 466 may be separate andoperatively connected by other means, such as by a shaft. In such aconfiguration, the housing 432 and the turbine housing 470 may also beseparate.

In operation, the OPEP device 430 administers OPEP therapy to a userwhen it is hooked up to a source of compressed air and a user exhalesinto a mouthpiece 439. As compressed air is forced into the turbinehousing 470 through the compressed air inlet 462, the turbine 466 beginsto rotate. Because the turbine 466 is connected to the restrictor member442, rotation of the turbine 466 also causes the restrictor member 442to rotate. As the restrictor member 442 rotates, and as blockingsegments 446 pass by a chamber inlet 436, the exhalation pressure at thechamber inlet 436 oscillates between a minimum when the restrictormember 442 is an open position and a maximum when the restrictor member442 is in a closed position.

Referring to FIG. 12, a cross-sectional perspective view of a fifthembodiment of an OPEP device 530 is shown. The OPEP device 530 isadapted to provide OPEP therapy using the force of air exhaled into themouthpiece 539 to rotate the restrictor member 542, without the aid of amotor or compressed air. In general, the OPEP device 530 includes ahousing 532, an interior chamber 534, a chamber inlet 536, a chamberoutlet 538, an exhalation flow path 540, and a restrictor member 542.

The restrictor member 542 in the OPEP device 530 includes a plurality ofvanes 567 adapted to rotate the restrictor member 542 when a userexhales into the mouthpiece 539. The restrictor member 542 also includesa blocking segment 546 formed between two adjacent vanes 567. Thus, whena user exhales into the mouthpiece 539, air is forced through thechamber inlet 536 and the restrictor member 542 begins to rotate. As therestrictor member rotates, and as the blocking segment 546 periodicallypasses by the chamber inlet 536, the exhalation pressure at the chamberinlet 536 oscillates between a minimum when the restrictor member 542 isin an open position and a maximum when the restrictor member 542 is in aclosed position.

When the user stops exhaling into the OPEP device 530, the restrictormember 542 comes to a rest. As shown in FIG. 13, the restrictor member542 may come to rest in a closed position where the blocking segment 546is substantially blocking the flow path 540 through the chamber inlet536. If the restrictor member 542 comes to rest in a closed position, asufficient amount of exhaled air may not enter the interior chamber 534to initiate the rotation of the restrictor member 542.

As shown in FIG. 14, the restrictor member 542 may therefore be weightedto have a center of gravity 572 offset from its axis of rotation. Basedon the location of the center of gravity 572 of the restrictor member542, gravity may be used to ensure that the restrictor member 542 comesto rest in an open position when the OPEP device 530 is held upright.

Alternatively, as shown in FIG. 15, the housing 532 of the OPEP device530 may also include a one-way valve 574 configured to allow air toenter the interior chamber 534 through the valve opening 575 uponinhalation. The one-way valve 574 prevents air from exiting the interiorchamber 534 during exhalation. In this configuration, the OPEP device530 is adapted to restrict exhaled air flowing out of the interiorchamber 534 at the chamber outlet 538. Thus, when a user exhales intothe mouthpiece 539 and through the chamber inlet 536, the restrictormember 542 rotates, and the blocking segment 546 periodically restrictsthe flow of exhaled air through the chamber outlet 538. As the userexhales, the exhalation pressure at the chamber outlet 538 oscillatesbetween a minimum and a maximum in the same manner as explained above,which is effectively transmitted back to the user for the administrationof OPEP therapy. In this configuration, the chamber inlet 536 is largeenough such that the blocking segment 546 does not substantiallyrestrict the cross sectional area of the flow path 540 through thechamber inlet 536.

However, if the restrictor member 542 comes to rest in a position wherethe blocking segment 546 is restricting the flow of air through thechamber outlet 538, a sufficient amount of exhaled air may not passalong the exhalation flow path 540 through the chamber outlet 538 toinitiate rotation of the restrictor member 542. In this situation, auser may inhale to open the one-way valve 574 and permit air to flowthrough the valve opening 575, into the interior chamber 534, andthrough the chamber inlet 536, thereby initiating rotation of therestrictor member 542, and moving the blocking segment 546 to a positionwhere it is not restricting the flow of air through the chamber outlet538. After the blocking segment 546 has moved to a position where it isnot restricting the flow of air through the chamber outlet 538, a usermay exhale to begin administration of OPEP therapy.

As in the previous embodiments, the housing 532 is preferably openableso that the housing 532 and the parts contained therein may beperiodically accessed, cleaned, or replaced. Referring to FIGS. 16A-C,top views of various restrictor members 542 are shown. The restrictormembers 542 may have any number of vanes 567 and blocking segments 546.Furthermore, the blocking segments 546 may extend only a portion of theway between adjacent vanes 567. In this regard, the OPEP device 530 ishighly configurable to achieve a specific oscillating frequency of theexhalation pressure. A user of the OPEP device 530 can change theoscillation frequency by simply selecting a different restrictor member542 and replacing the existing restrictor member 542 in the OPEP device530.

Referring to FIGS. 17-18, a cross-sectional view of a sixth embodimentof an OPEP device 630 is shown. The OPEP device 630 is adapted toprovide both OPEP therapy and, when connected to a nebulizer 652, thesimultaneous administration of OPEP and aerosol therapies. In thisembodiment, the OPEP device 630 includes a respiratory portal 654 forfluidly interconnecting a mouthpiece 639, a chamber inlet 636, and anebulizer port 656.

As shown in FIG. 17, the OPEP device 630 is configured for the deliveryof OPEP therapy only. In this configuration, the OPEP device 630 mayinclude an end cap 658 for regulating the flow of air through thenebulizer port 656. The end cap 658 may include a one-way valve 659configured so that air may enter the respiratory portal 654 through thenebulizer port 656 on inhalation, but block the flow of air out of thenebulizer port 656 upon exhalation. Thus, a user may inhale air throughthe one way valve 659 and the mouthpiece 639 upon inhalation, and uponexhalation, receive OPEP therapy as the one way valve 659 closes andexhaled air is forced through the chamber inlet 636. At the chamberinlet 636, a flow path 640 is periodically restricted by a rotatingrestrictor member 642, thereby generating an oscillating exhalationpressure as previously described. As explained above in reference toFIGS. 12-14, the restrictor member 642 may also be weighted to have acenter of gravity 672 offset from its axis of rotation so that it comesto rest in an open position when the OPEP device 630 is held upright.

As shown in FIG. 18, the OPEP device 630 is connected to the nebulizer652 and configured for the simultaneous administration of OPEP andaerosol therapies. In this configuration, the end cap 658 has beenremoved and a nebulizer output 660 has been attached to the nebulizerport 656 on the respiratory portal 654. A one-way valve is not neededwhen attached to the nebulizer 652 because most commercially availablenebulizers include a valve means for regulating the flow of the aerosolcontained therein. This configuration operates in the same manner asdescribed above in reference to FIG. 17, except that an aerosol is drawnfrom the nebulizer output 652 through the chamber inlet 636 uponinhalation. Thus, a user may simultaneously receive OPEP therapy uponexhalation and aerosol therapy upon inhalation.

An advantage of the embodiment of FIG. 18 is that an inhalation flowpath 641 from the nebulizer 656 to the user substantially avoids theexhalation flow path 640. As such, when the OPEP device 630 is connectedto the nebulizer 656 for example, aerosol medicament does not get stuckin the interior chamber 634. In this manner, loss of medicament andcontamination of the interior chamber 634 may be reduced.

In each of the embodiments described above, movement of the restrictormember from the closed position to an open position, or from an openposition to a closed position, does not depend on the exhalationpressure at the chamber inlet reaching a predetermined level, theattainment of which is necessarily influenced by various human factors,including the user's exhalation flow rate. In this manner, therestrictor member maintains a consistent oscillation frequency andimproves the effectiveness of OPEP therapy administered to users.

Although the description of the embodiments described above refer to theadministration of OPEP therapy on exhalation, it should be appreciatedthat such embodiments are also configurable for the administration ofoscillating pressure therapy upon exhalation only, inhalation only, orboth exhalation and inhalation. Accordingly, the terms “oscillatingpositive respiratory pressure” and “oscillating positive expiratorypressure,” or “OPEP,” may be used interchangeably. Similarly, the term“respiratory” may refer to inhalation, exhalation, or both inhalationand exhalation. Use of any such term should not be construed as alimitation to only inhalation or only exhalation.

The foregoing description of the inventions has been presented forpurposes of illustration and description, and is not intended to beexhaustive or to limit the inventions to the precise forms disclosed. Itwill be apparent to those skilled in the art that the present inventionsare susceptible of many variations and modifications coming within thescope of the following claims.

What is claimed is:
 1. An oscillating positive respiratory pressureapparatus comprising: a housing having an interior chamber; a chamberinlet in communication with the chamber; a chamber outlet incommunication with the chamber; an exhalation flow path defined betweenthe inlet and the outlet; and, a restrictor member rotatably mountedwithin the interior chamber, the restrictor member having an axis ofrotation substantially perpendicular to the exhalation flow path at theinlet, the restrictor member having at least one blocking segment;wherein the restrictor member is movably positioned with respect to theinlet such that rotation of the restrictor member moves the at least oneblocking segment between an open position where the exhalation flow pathat the inlet is unrestricted and a closed position where the exhalationflow path at the inlet is restricted, and wherein exhalation pressure atthe inlet oscillates between a minimum when the at least one blockingsegment is in the open position and a maximum when the at least oneblocking segment is in the closed position.
 2. The oscillating positiverespiratory pressure apparatus of claim 1, further comprising a shaftconnecting a source of rotational energy to the restrictor member. 3.The oscillating positive respiratory pressure apparatus of claim 2,wherein the source of rotational energy comprises a motor adapted torotate the shaft.
 4. The oscillating positive respiratory pressureapparatus of claim 1, further comprising a second restrictor memberrotatably mounted within the interior chamber and operatively connectedto the shaft, the second restrictor member having at least one blockingsegment, wherein the shaft is moveable along its axis of rotation toposition the second restrictor member with respect to the inlet suchthat rotation of the shaft moves the second restrictor member betweenthe open position and the closed position.
 5. The oscillating positiverespiratory pressure apparatus of claim 4, wherein a number of blockingsegments on the restrictor member and a number of blocking segments onthe second restrictor member are different.
 6. The oscillating positiverespiratory pressure apparatus of claim 1, further comprising a turbineoperatively connected to the restrictor member and adapted to rotate therestrictor member in response to receiving a flow of air.
 7. Theoscillating positive respiratory pressure apparatus of claim 6, furthercomprising a turbine housing surrounding the turbine, the turbinehousing having a compressed air inlet configured to receive compressedair from a compressed air source and an exhaust outlet.
 8. Theoscillating positive respiratory pressure apparatus of claim 1, furthercomprising a respiratory portal in fluid communication with the inlet,the respiratory portal including a mouthpiece and a nebulizer port. 9.The oscillating positive respiratory apparatus of claim 8, wherein themouthpiece is proximate the nebulizer port.
 10. The oscillating positiverespiratory pressure apparatus of claim 8, further comprising aninhalation flow path defined between the mouthpiece and the nebulizerport, wherein the inhalation flow path does not traverse the exhalationflow path defined between the inlet and the outlet.
 11. The oscillatingpositive respiratory pressure apparatus of claim 1, wherein therestrictor member is configured to rotate in response to exhaled airtraversing the exhalation flow path.
 12. The oscillating positiverespiratory pressure apparatus of claim 1, wherein the restrictor memberis configured to move between the open position and the closed positionindependent of the exhalation pressure at the inlet.
 13. The oscillatingpositive respiratory pressure apparatus of claim 1, wherein therestrictor member is removably mounted within the interior chamber. 14.An oscillating positive respiratory pressure apparatus comprising: ahousing having an interior chamber; a chamber inlet in communicationwith the chamber; a chamber outlet in communication with the chamber; anexhalation flow path defined between the inlet and the outlet; and, arestrictor member rotatably mounted within the interior chamber, therestrictor member having at least one blocking segment and a pluralityof vanes configured to rotate the restrictor member in response toexhaled air traversing the exhalation flow path; wherein the restrictormember is positioned with respect to one of the inlet or the outlet suchthat rotation of the restrictor member moves the at least one blockingsegment between an open position where the exhalation flow path at theone of the inlet or the outlet is unrestricted and a closed positionwhere the exhalation flow path at the one of the inlet or the outlet isrestricted, and wherein exhalation pressure at the inlet oscillatesbetween a minimum when the at least one blocking segment is in the openposition and a maximum when the at least one blocking segment is in theclosed position.
 15. The oscillating positive respiratory pressureapparatus of claim 14, wherein the at least one blocking segment has across-sectional area greater than a cross-sectional area of the one ofthe inlet or the outlet.
 16. The oscillating positive respiratorypressure apparatus of claim 14, wherein the housing includes a one-wayvalve configured to allow air to enter the interior chamber through avalve opening.
 17. The oscillating positive respiratory pressureapparatus of claim 14, wherein a center of gravity of the restrictormember is radially offset from an axis of rotation of the restrictormember.
 18. The oscillating positive respiratory pressure apparatus ofclaim 14, wherein an axis of rotation of the restrictor member issubstantially perpendicular to the exhalation flow path at the one ofthe inlet or the outlet.
 19. The oscillating positive respiratorypressure apparatus of claim 14, wherein the at least one blockingsegment is configured to move between the open position and the closedposition independent of the exhalation pressure at the inlet.
 20. Theoscillating positive respiratory pressure apparatus of claim 14, furthercomprising a respiratory portal in fluid communication with the inlet,the respiratory portal including a mouthpiece and a nebulizer port.